PLOT NO.116, 116B 126C, S.V. CO OP. IND. ESTATE...

DR. REDDY’S LABORATORIES LTD. CHEMICAL TECHOPS – III

PLOT NO.116, 116A, 116B & 126C, S.V. CO‐OP. IND. ESTATE, BOLLARAM VILLAGE, JINNARAM MANDAL,

MEDAK DISTRICT, TELANGANA

FORM I

Project No. 1114‐21‐06November 2014

DR. REDDY’S LABORATORIES LTD. Regd. Office : 8‐2‐337, Road No.3, Banjara Hills, Hyderabad – 500 034. Phone: 040 4900 2900 Fax: 040 4900 2999 E‐mail: [email protected], [email protected]

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO MINISTRY OF ENVIRONMENT AND FORESTS,

GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

Chemical Tech Ops ‐ III

Form I Page 1

APPENDIX – I (See Paragraph – 6)

FORM I

I) Basic Information S.No. Item Details 1 Name of the Project/s Dr. Reddy’s laboratories Ltd,

Chemical Tech Ops ‐ III 2 S. No in the Schedule 5 f – A category 3 Proposed capacity/area/length/tonnage

to be handled/command area/lease area/number of wells to be drilled

Proposed to enhance the production capacity of Active Pharma Ingredients (API’s) from 4.45 TPM to 28.1 TPM and inclusion of Solvent Recovery System Cost of the project (Expansion): 12 Crores

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 4.45 TPM

Area Existing: 5.77 Acres 6 Category of Project i.e 'A' or 'B' “A” 7 Does it attract the general condition? If

yes, please specify Yes. The Unit is Located in Notified Industrial Estate / Area. The project site is located in Bollaram and Patancheru Industrial Estates (IE’s), Office Memorandum (OM) No. J‐11013/5/2010‐IA.II(I) dated 10.06.2014 mandated that projects required EC in these areas will be considered by MoEF.

8 Does it attract the Specific condition? If yes, please specify.

No

9 Location Plot/Survey/Khasra No. Plot. Nos. 116, 116A, 116B & 126C

S.V. Cooperative Industrial Estate, IDA, Bollaram Village Bollaram (V) Tehsil Jinnaram (M) District Medak District State Telangana

10 Nearest railway station/airport along with distance in kms.

Railway Station: Bollaram – 18 Km Airport : Rajiv Gandhi Interna onal Airport – 34.25 Km

11 Nearest Town, City, District Headquarters along with distance in kms.

Town & District HQ – Sangareddy ‐ 60 KM City ‐ Hyderabad ‐ 22.6 KM

12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone nos. to be given)

Bollaram Village


Form I Page 2

13 Name of the Applicant J. Shravan Kumar 14 Registered Address Dr. Reddy’s Laboratoires Limited

Regd. Office : 8‐2‐337, Road No.3, Banjara Hills, Hyderabad – 500 034

15 Address for Correspondence: Name J. Shravan Kumar Designation(Owner/Partner/CEO) Associate Director ‐ Operations Address Plot. Nos. 116, 116A, 116B & 126C,

S.V. Cooperative Industrial Estate, Bollaram IDA, Jinnaram (M), Medak (Dist), Telangana

Pin Code 502 325 E‐mail [email protected],

[email protected] Telephone Number Direct : +91‐ 8458 279485

Mobile : +91 9866002540 Fax No. +91‐ 8458 279619

16 Details of alternative Sites examined, if any. Location of these sites should be shown on a topo sheet.

‐NA‐

17 Interlinked Projects ‐NA‐ 18 Whether separate application of

interlinked project has been submitted? No

19 If yes, date of submission 20 If no, reason 21 Whether the proposal involves

approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972? (c) The C.R.Z Notification, 1991?

‐NA‐

22 Whether there is any Government Order/Policy relevant/relating to the site?

No

23 Forest land involved (hectares) No 24 Whether there is any location pending

against the project and /or land in which the project is propose to be set up? (a) Name of the Court (b) Case No (c) Orders/directions of the Court, if any and its relevance with the proposed project.

No Individual Court case against the Project.

However Green Tribunal Case, W.P. No. 19661 of 2002 on the file of Hon’ble High Court of Andhra Pradesh / Application No. 90 of 2013 before NGT is filed against CETP Members. (Presently our CETP Membership is limited to emergency usage as the plant has ZLD based effluent Treatment System)


Form I Page 3

(II) Activity

1. Construction, operation or decommissioning of the Project involving actions, which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities

/rates, wherever possible) with source of information data

1.1 Permanent or temporary change in land use, land cover or topography including increase in intensity of land use (with respect to local land use plan)

NO The proposal is for expansion of API’s manufacturing capacity and inclusion of Solvent Recovery System (SRS) in the existing unit. No additional land. Total Land area after proposed expansion 5.77 Acres.

1.2 Clearance of existing land, vegetation and buildings?

NO Industrial

1.3 Creation of new land uses? NO 1.4 Pre‐construction investigations e.g.

bore houses, soil testing? YES Soil Testing completed

1.5 Construction works?

YES Construction activity involves creation of new additional utilities like Boiler, Chilling Plant etc and enhancement of treatment system.

1.6 Demolition works? NO

1.7 Temporary sites used for construction works or housing of construction workers?

NO Construction labor from local villages shall be employed.

1.8 Above ground buildings, structures orearthworks including linear structures, cut and fill or excavations

YES Storage facilities shall be constructed. No major cut and fill or excavation is anticipated.

1.9 Underground works including mining or tunneling?

NO

1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing

processes? YES Enclosed in Annexure – I

1.14 Facilities for storage of goods or materials?

NO Raw materials and solvents shall be stored with safety precautions.

1.15 Facilities for treatment or disposal of solid waste or liquid effluents?

YES Solid waste shall be disposed to end users/recyclers or sent to incineration. Effluent generated from the plant are treated and reused. Details presented in Annexure II


Form I Page 4

1.16 Facilities for long term housing of operational workers?

NO Local people shall be employed.

1.17 New road, rail or sea traffic during construction or operation?

NO

1.18 New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc?

NO

1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?

NO

1.20 New or diverted transmission lines or pipelines?

NO

1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?

NO

1.22 Stream crossings? NO 1.23 Abstraction or transfers of water

form ground or surface waters? YES Total water required shall increase from 88.5

KLD to 330.5 KLD out of which 216.5 KLD shall be met from APIIC (Industrial supply) and the balance shall be recycled water.

1.24 Changes in water bodies or the land surface affecting drainage or run‐off?

NO

1.25 Transport of personnel or materials for construction, operation or decommissioning?

YES The construction material shall be drawn from local sources within 10 – 15 km. There is no transport of personnel, as the construction workers shall be drawn from local villages.

1.26 Long‐term dismantling or decommissioning or restoration works?

NO

1.27 Ongoing activity during decommissioning which could have an impact on the environment?

NO

1.28 Influx of people to an area in either temporarily or permanently?

YES The proposed project shall increase the employment potential and hence may lead to migration to surrounding villages.

1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic

diversity? NO

1.31 Any other actions? NO


Form I Page 5

2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non‐renewable or in short supply): S.No. Information/checklist confirmation Yes/No Details thereof (with approximate quantities

/rates, wherever possible) with source of information data

2.1 Land especially undeveloped or agricultural land (ha)

NO Existing Unit

2.2 Water (expected source & competing users) unit: KLD

YES Total water required shall increase from 88.5 KLD to 330.5 KLD out of which 216.5 KLD shall be met from APIIC (Industrial supply) and the balance shall be recycled water. (Water Balance Enclosed in Annexure III)

2.3 Minerals (MT) NA 2.4 Construction material – stone,

aggregates, sand / soil (expected source – MT)

YES Shall be sourced from the local villages.

2.5 Forests and timber (source – MT) NO 2.6 Energy including electricity and fuels

(source, competing users) Unit: fuel (MT), energy (MW)

YES The required energy shall be drawn from APTRANSCO. The power shall be drawn from existing DG sets during load shut downs. Backup DG sets of 1x320 KVA, 1 x 250KVA and 1 x 500KVA existing, 1 x 1450KVA, 1 x 1010KVA additional shall be provided to cater to energy requirement during load shut downs. The other energy source is oil Fired Boiler of 1 x 3TPH Fuel quantity is 200 lts/hr.

2.7 Any other natural resources (use appropriate standard units)

NA


Form I Page 6

3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health. S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data

3.1 Use of substances or materials, which are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies)

YES Solvents shall be used as reaction media. MSIHC rules shall be followed during storage, transportation and handling of raw materials and hazardous chemicals.

3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases).

NO

3.3 Affect the welfare of people e.g. by changing living conditions?

YES Shall increase the employment potential for locals and affect the living conditions for betterment.

3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc.,

NO No sensitive receptors are present in the immediate vicinity of the site. The project shall not have any significant impact on vulnerable groups of people.

3.5 Any other causes NO

4. Production of solid wastes during construction or operation or decommissioning (MT/month) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


4.1 Spoil, overburden or mine wastes NO 4.2 Municipal waste (domestic and or

commercial wastes) NO Wastes from canteen, other commercial

wastes like paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 15kg/day

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES The quantity of hazardous waste generated during operation contain salts from evaporators, stripper distillate, process residue, and solvent residues, ETP sludge and filtration media etc. enclosed in Annexure – IV

4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO


Form I Page 7

4.6 Sewage sludge or other sludge from effluent treatment

YES Sludge from Effluent treatment plant and Salts from MEE & ATFD shall be sent to TSDF.

4.7 Construction or demolition wastes YES Construction activity involves creation of new additional utilities like boiler, Chilling Plant etc and enhancement of treatment system.

4.8 Redundant machinery or equipment NO

4.9 Contaminated soils or other materials NO

4.10 Agricultural wastes NO

4.11 Other solid wastes NO Enclosed at Annexure IV

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


5.1 Emissions from combustion of fossil fuels from stationary or mobile sources

YES Quantity of fuel and emissions details are enclosed in Annexure V

5.2 Emissions from production processes YES Enclosed in Annexure ‐ VI 5.3 Emissions from materials handling

including storage or transport NO Material transfer takes place in closed

pipeline systems. 5.4 Emissions from construction activities

including plant and equipment YES Dust may rise during transport of material and

construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises.

5.5 Dust or odors from handling of materials including construction materials, sewage and waste

YES Dust may rise during transport of material and construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises.

5.6 Emissions from incineration of waste NO 5.7 Emissions from burning of waste in

open air (e.g. slash materials, construction debris)

NO

5.8 Emissions from any other sources NO


Form I Page 8

6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist

confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data with source of information data

6.1 From operation of equipment e.g. engines, ventilation plant, crushers

YES Material transport and construction equipment shall be source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation.

6.2 From industrial or similar processes

YES DG sets, controlled by providing Acoustic Enclosures.

6.3 From construction or demolition YES Noise during construction shall be due to construction equipment and emergency DG sets.

6.4 From blasting or piling NO

6.5 From construction or operational traffic

NO The increased traffic shall not have any significant impact.

6.6 From lighting or cooling systems NO

6.7 From any other sources NO

7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea: S.No. Information/Checklist

confirmation Yes/No Details thereof (with approximate


7.1 From handling, storage, use or spillage of hazardous materials

NO All the hazardous materials will be stored in MS drums, in a covered shed and no contamination of soil is expected

7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge)

NO All the wastes from domestic operations are sent to Biological effluent treatment plant.

7.3 By deposition of pollutants emitted to air into the land or into water

NO All the emissions from process are controlled by providing control equipment like scrubbers, Dust Collectors and emissions from boilers effective stack height.

7.4 From any other sources NO 7.5 Is there a risk of long term build

up of pollutants in environment from these sources?

NO


Form I Page 9

8.Risk of accidents during construction or operation of the Project, which could affect human health or the environment S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances

YES All Inbuilt Safety precautions will be adopted and there will not be any damage to environment or human health

8.2 From any other causes NA 8.3 Could the project be affected by natural

disasters causing environmental damage (e.g? Floods, earthquakes, landslides, cloudburst etc)?

NO

9.Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality S. No. Information/Checklist confirmation Yes/No Details thereof (with approximate


9.1 Lead to development of supporting. facilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.: • Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.)• housing development • extractive industries • supply industries • other

YES The project shall enhance the socio economic status of the area by increasing the demand for housing, improving the employment. There are no major support industries required for this plant.

9.2 Lead to after‐use of the site, which could haven impact on the environment

NO

9.3 Set a precedent for later developments NO 9.4 Have cumulative effects due to proximity to

other existing or planned projects with similar effects

NO The baseline environmental status of the surrounding areas is within the prescribed limits as observed from the Secondary data.


Form I Page 10

(III) Environmental Sensitivity S.No. Areas Name/

IdentityAerial distance (within 15 km.) Proposed project location boundary

1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value

NA

2 Areas which are important or sensitive for ecological reasons ‐ Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests

YES Wailal RF – N – 6.4 Km Pottaguda RF – NW ‐ 8.7 Km Kazipalli RF – N – 3.2 Km Kodakanchi RF – NW – 8.9 Km Dundigal RF – NE – 8.6 Km Suraram RF – E – 9.4 Km Gajularamaram RF – E – 9.2 Km Borampet RF – E – 9 Km

3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

NA

4 Inland, coastal, marine or underground waters NO 5 State, National boundaries NO 6 Routes or facilities used by the public for access

to recreation or other tourist, pilgrim areas NO

7 Defense installations NO 8 Densely populated or built‐up area YES Bollaram – 1.1 Km. 9 Areas occupied by sensitive man‐made land

uses (hospitals, schools, places of worship, community facilities)

NA 2 Km away from the site

10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)

NO

11 Areas already subjected to pollution or environmental damage. (those where existing legal environmental standards are exceeded)

YES Bollaram and Patancheru Industrial areas at a distance of 1.1Km.

12 Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

NO


Form I Page 11

(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA “...The EIA shall cover the following: Description of the proposed project: The first task:” Description of the proposed project” forms a vital component of the Environmental Impact Assessment (EIA) as it provides the basis for evaluating the likely causes of Environmental Impacts.

Existing Environment and Baseline Conditions: The baseline assessment will be carried out to identify potentially sensitive and critical areas that may be affected by the project in an area of 10 km surrounding the project location. The critical and sensitive targets shall be plotted on land use map of project impact area. The existing environment and baseline conditions should be established from:‐ Analysis of existing information published and secondary data. ‐Consultation with relevant statutory authorities, and Field visits for supplementation of missing gaps.

The key subject areas which the EIA shall address include Ecology and Nature conservation, Air quality, surface and water quality in project impact area, soil quality, cultural heritage, landscape, land use, noise quality, etc. Natural habitats like national parks, wildlife reserves, sanctuaries, sacred grove, protected areas, forests, wetlands, major rivers and waterways if any, shall also be identified and marked.

Assessment of Environmental Impacts: Based upon the results from the review of existing information, field visits, site data collection and consultation, for each component of environment (physical, biological and socio economic) the positive, negative, direct and indirect, temporary and permanent impacts will be evaluated along with an indication of the degree of impact, i.e., whether the impact is significant, moderate, minor or negligible. The degree of impact shall also be quantified by using state of the art air quality impact prediction models based on ISCST3 algorithms.

Environment Management Plan And Mitigation Plan: For each significant negative impact identified, specialist shall work closely with the engineering team/technical consultants to suggest practicable measures to avoid or mitigate the impact. The mitigation of environmental impacts will be by three mechanisms. =>Introduction of mitigation features through the engineering practices. =>Implementation of environmental controls during construction and operation. =>Legislative control involving compliance with Indian environmental laws. The Environmental management plan shall include an estimate of capital and recurring costs of mitigation measures and will identify the institutional framework for implementation.

Monitoring Plan: Having identified the significant environmental impact that is likely to arise as a result of the project, the project team shall specify what monitoring is required during the various phases of the project cycle. The monitoring plan will identify parameters and frequency of monitoring and responsible organization.


Form I Page 12

I hereby give the undertaking that data and information given in the application and enclosures are true to the best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to be false or misleading at any stage, the project will be rejected and clearance given, if any to the project will be revoked at our risk and cost.

Date:

Place:

Signature of the applicant With Name and Full Address

(Project Proponent/Authorized Signatory)

J. Shravan Kumar Director & Location Head CTO 3

Plot. Nos. 116, 116A, 116B & 126C, Dr. Reddy’s Laboratories Ltd., Chemical TechOps – III

S.V. Cooperative Industrial Estate, Bollaram IDA, Jinnaram (M), Medak (Dist),

Telangana – 502 325




ANNEXURES

SUBMITTED TO MINISTRY OF ENVIRONMENT AND FORESTS,

GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

Chemical TechOps ‐ III Form I Annexures

Page 1

Loca

tion

Map

of D

r. re

ddy’

s La

bora

tori

es L

td.,

Che

mic

al T

echO

ps II

I


Page 2

W

ES

ND

.R

eddy

'sD

.R

eddy

'sR

RLa

bora

torie

s Ltd

.C

.T.O

UN

IT-II

I

BO

LLA

RA

M, H

YD

ERA

BAD

-55

Plan

t Lay

out o

f Dr.

redd

y’s

Labo

rato

ries

Ltd

., C

hem

ical

Tec

hOps

III


Page 3

ANNEXURE - I

M/s. Dr. Reddy’s Laboratories Ltd., CTO Unit I obtained consent for establishment and

operation for Bulk Drugs & intermediates at Plot. Nos. 116, 116A, 116B & 126C, S.V.

Cooperative Industrial Estate, IDA, Bollaram, Jinnaram Mandal, Medak District,

Telangana. It is proposed to expand the manufacturing capacity of API’s with inclusion of

Solvent Recovery System. The expansion entails a capital cost of Rs. 12 crores towards

modernization of zero liquid discharge facility, debottlenecking by way of incorporating

the advanced technology and state of the art equipment. Manufacturing capacity is

presented in Table A-1. The proposed manufacturing capacity is presented in Table A-2.

Table A-1 Manufacturing Capacity – Permitted

S. No Product Name Quantity (Kg/Day) Combination 1 Combination 2 Combination 3

1 Esomeprazole Magnesium 8.33 8.33 5.56 2 Omeprazole 5.56 5.0 2.78 3 Omeprazole Magnesium 16.67 20.82 19.44 4 Omeprazole Sodium 1.11 1.11 1.11 5 Pantoprazole Sodium 1.11 1.11 1.39 6 Rabeprazole Sodium 50.51 49.67 37.17 7 Amlodipine Besylate 1.11 1.11 2.78 8 Amlodipine Maleate 1.39 1.39 1.39 9 Lacidipine 3.33 0.56 0.56

10 Alendronate Sodium 8.89 8.89 8.89 11 Aprepitant 0.56 0.56 0.56 12 Levocetirizine

Hydrochloride 8.61 8.61 8.61

13 Ramipril 30.56 30.56 40.56 14 Ropinirole Hydrochloride 0.56 0.56 0.56 15 Terbinafine Hydrochloride 2.78 2.78 9.72 16 Tizanidine Hydrochloride 4.17 4.17 4.17 17 Zoledronic Acid 0.01 0.01 0.01 18 Atomoxitine HCl 3.06 3.06 3.06 19 Disodium Pamidronate 0.03 0.03 0.03

Total 148.33 148.33 148.33


Page 4

Table A-2 Manufacturing Capacity – After Expansion

S.No Name of the Product CAS No. Capacity TPM Kg/day

1 Esomeprazole Mg 161973-10-0 2 66.67 2 Omeprazole 73590-58-6 4 133.33 3 Omeprazole Magnesium 95382-33-5 1.5 50 4 Omeprazole Sodium 95510-70-6 0.3 10 5 Omerprazole Form B 73590-58-6 1 33.33 6 Pantoprazole Sodium 138786-67-1 3 100 7 Rabeprazole Sodium 117976-90-6 2.5 83.33 8 Amlodipine Besylate 111470-99-6 4 133.33 9 Amlodipine Maleate 88150-47-4 0.9 30

10 Lacipidine 103890-78-4 0.15 5 11 Alendronate Sodium Trihydrate 121268-17-5 0.2 6.67 12 Apprepitant 170729-80-3 0.1 3.33 13 Levocetrizine Di HCl 130018-87-0 0.3 10 14 Ramipril 87333-19-5 3 100 15 Terbinafine HCl 78628-80-5 4 133.33 16 Tizanidine HCl 64461-82-1 0.5 16.67 17 Zolendronic Acid 118072-93-8 0.01 0.33 18 Atomoxeline HCl 82248-59-7 0.05 1.67 19 Disodium Pamidronate 57248-88-1 0.01 0.33 20 Ropinrole HCl 91374-20-8 0.055 1.83 21 Lansoprozole 103577-45-3 0.25 8.33 22 Voriconazole 137234-62-9 0.25 8.33 23 R&D Products 0.03 1

Total 28.1 936.83


Page 5

Process Description of Omeprazole

Chemical Reaction of Omeprazole

Process Description for Omeprazole

Stage-1: 2,3-Dichlorobenzoyl Cyanide with Acetonitrile in the presence of

Aminoguanidine Bicarbonate and Sulfuric Acid undergoes schiffbase reaction to get

Lamotrigine (Crude).

Stage-2: Lamotrigine (Crude) purify in the presence of Methanol to get Lamotrigine

(Pure). The process flow diagram is presented in Fig A-1 and material balance is

presented in Table A-3.

2,3-Dichlorobenzoyl Cyanide

Aminoguanidine Bicarbonate Sol.Recovery Acetonitrile Evaporation Loss Sulfuric Acid Effluent Methanol Organic Residue Sodium Hydroxide Process Emissions Water

Lamotrigine (Crude) Sol.Recovery Methanol Evaporation Loss

Organic Residue

Lamotrigine

Fig A-1 Process Flow Diagram of Omeprazole


Page 6

Table A-3 Material Balance for Omeprazole Stage I Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

2-Chloromethyl-4-methoxy-3,5-dimethyl pyridine HCl

340 Stage I Product 227.0 Stage I Product

2-Mercapto-5-methoxy benzimidazole

276 Water formed in reaction 24.8 To wastewater

Sodium Hydroxide 322.7 Sodium Chloride 80.7 To wastewater Chloroform 1800 Chloroform Recovered 1737 Recovered & reused Water 2733.3 Chloroform Loss 5 Fugitive loss Chloroform to Residue 59 Solvent in residue 2-Chloromethyl-4-methoxy-

3,5-dimethyl pyridine HCl 187 Organic Residue

2-Mercapto-5-methoxy benzimidazole

151.8 Organic Residue

Inorganics Sodium Hydroxide 267.5 To wastewater Water 2733 To wastewater Total Input 5472.5 Total Output 5472.5 Stage II Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

Stage I Product 227.0 Omeprazole 133.3 Final Product Peracetic Acid 52.4 Sodium Acetate 31.7 To wastewater Sodium Hydroxide 234.6 Water formed in reaction 7 To wastewater Acetone 2000 Methanol Recovered 1665 Recovered & reused Methanol 1800 Methanol Loss 4.5 Fugitive loss Chloroform 700 Methanol to Wastewater 9 To wastewater Water 5000 Methanol to Residue 121.5 Solvent in residue Acetone Recovered 1906 Recovered & reused Acetone Loss 7 Fugitive loss Acetone to Wastewater 12 To wastewater Acetone to Residue 75 Solvent in residue Chloroform Recovered 676 Recovered & reused Chloroform Loss 2 Fugitive loss Chloroform to Residue 23 Solvent in residue Stage I Product 100 Organic residue Peracetic Acid 23 To wastewater Sodium Hydroxide 219.1 To wastewater Water 5000 To wastewater Total Input 10014.1 Total Output 10014.1


Page 7

ANNEXURE – II: Wastewater Treatment Facilities

The effluent generated from the proposed expansion of M/s. Dr. Reddy’s Laboratories

ltd., CTO Unit III is mainly from process, washings, scrubbers, cooling towers & boiler

blow downs, RO/DM rejects from pre-treatment of water and domestic effluent. Effluent

from process, washings, scrubbers and RO/DM rejects from pre-treatment sent to

Stripper, Multiple Effect Evaporator followed by ATFD, Biological treatment and RO.

Effluent from Cooling towers and boiler bow downs along with condensate from MEE

and ATFD and domestic effluent will be sent to Biological treatment system followed by

RO. The treated effluent shall be reused for cooling towers. Total Effluent generated and

mode of treatment before and after expansion is presented in Table A-4 and A-5

respectively and quantity and quality of effluent generated from process after expansion is


Table A-4 Quantity of Effluent Generated – Permitted

S.No Description Quantity KLD

Treatment/Disposal

1 Process, Washings, Scrubber & R&D

11.9 Shall be sent to Waste water recycling facility (WWRF) at Dr. Reddy’s Laboratories Ltd., CTO Unit – II, IDA Bollaram consisting of Stripper, Multiple Effect Evaporator system followed by Spray drier. Stripper condensate to distillate for recovery of organics. Stripped effluents to forced evaporation in the MEE & spray drier. Condensate of MEE to ETP.

2 Blow downs 2 Waste water recycling facility (WWRF) at Dr. Reddy’s Laboratories Ltd., CTO Unit – II, IDA Bollaram for treatment in the ETP. Treated effluents for filtration in the RO plant. RO permeate to reuse. RO rejects to MEE & spray drier for evaporation.

3 Domestic 15

Total 28.9


Page 8

Table A-5 Quantity of Effluent Generated – After Expansion (Tentative)

S.No Description Quantity (KLD)

Treatment/Disposal

1 Process Effluent 44.2 After Pre treatment sent to Waste water recycling facility (WWRF at CTO II) having Stripper, Multiple Effect Evaporator followed by ATFD and condensate to biological treatment. RO is provided for tertiary treatment.

2 Washings Effluent 10 3 Scrubber Effluent 10 4 R & D Effluent 10 5 DM/RO Rejects from pre-

treatment of raw water 25

Total HTDS - I 99.2 6 Boiler Blow Down 2 After pre treatment sent to Waste water recycling facility (WWRF at CTO II) having Reverse Osmosis System and Multiple Effect Evaporator System.

7 Cooling tower Blowdown 23 8 Domestic Effluent 23.5

Total HTDS - I 48.5 Grand Total (I+II) 147.7


Page 9

Table A-6 Quantity and Quality of Effluent Generated from Process (Tentative)

S.No Name of the Product Quantity (Kg/Day) Concentration (mg/l)

Water TDS COD Total Effluent

TDS COD

1 Esomeprazole Magnesium 1743.1 230.6 17.9 1989.2 95906 9007 2 Omeprazole 7733.3 531.2 27.7 8437.7 62955 3287 3 Omeprazole Form - B 1933.3 382.8 6.9 2359.4 62245 2939 4 Omeprazole Magnesium 0 0 0 0 0 0 5 Omeprazole Sodium 11 0.8 0.3 12 70058 25354 6 Pantoprazole Sodium 2780 0.4 11.6 2843.7 134 4072 7 Rabeprazole Sodium 2750 35.8 2.5 4620.8 7755 541 8 Amlodipine Besylate 2012.4 0.0 242.9 2208 0 110016 9 Amlodipine Maleate 0 0 0 0 0 0 10 Lacidipine 2395 20.6 43.2 2437.2 8452 17705 11 Alendronate Sodium 568 43.7 3.5 614.3 71143 5697 12 Aprepitant 428.3 10.1 63.6 476.8 21150 133325 13 Levocetirizine Hydrochloride 1217 92.2 14.9 1356.4 67942 10971 14 Ramipril 8187.5 233.3 805.2 8537.5 27321 94310 15 Ropinirole Hydrochloride 77.2 5.5 1.4 90.1 61482 15778 16 Terbinafine Hydrochloride 3956.4 136.4 18.3 4324.9 31549 4237 17 Tizanidine Hydrochloride 1951.7 40.3 11.6 2013.5 19990 5769 18 Zoledronic Acid 30.7 3 1.7 37.4 80364 44102 19 Atomoxitine HCl 381.5 2.1 7.3 391 5390 18733 20 Disodium Pamidronate 17.8 4 0.6 23.7 70045 25150 21 Lansoprazole 216.7 14.3 17.8 244.9 58217 72848 22 Voriconazole 1009.7 23.7 2 1062.6 22346 1882 23 R & D Products 87.5 5.5 4.6 97.3 56604 47170

Total 39488 1816.3 1305.5 44178.3 41113 29551


Page 10

ANNEXURE – III: Water Balance

The total water requirement shall increased from 88.5 KLD to 330.5 KLD after expansion

out of which 216.5 KLD shall be drawn from APIIC (Industrial water supply) and balance

shall be recycled water. The water balance for daily consumption after expansion is


Table A-7 Total Water Balance – After Expansion (Tentative)

Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water

Recycled Water

Loss Effluent

Process 39.5 44.2* Washings 10 10 Scrubber 10 10 R& D 10 10 Boiler Feed 22 24 42 2 Cooling Tower 55 90 122 23 Additional water required for pretreatment of water in RO/DM Plant

25 25

Domestic 25 1.5 23.5 Gardening 20 20 Gross Total 216.5 114 185.5 147.7 Total 330.5 333.2

* Process effluents contain soluble raw materials, byproducts, solvents etc.


Page 11

ANNEXURE – IV: Solid Waste

Solid wastes are generated from the process shall be sent to TSDF/ Cement Industries for

Co-incineration. Stripper distillate shall send to TSDF/ Cement Industries for Co-

incineration. Evaporation salts from MEE and ATFD and ETP Sludge shall be sent to

TSDF. The total solid waste generated and mode of disposal is presented in Table A-8

and A-9 respectively.

Table A-8 Solid Waste Details – Permitted S.No Name of the Hazardous

waste Units Quantity Disposal

1 Process Residues (Organic Residue / Distillation Bottom residue)

TPM 5 Shall be disposed to cement plants for co-processing or to TSDF for incineration.

2 Organic Residues from SRS Distillation Bottom

TPM 30

3 Spent DMSO KL/Month 5 4 Spent Carbon TPM 0.6 5 Forced Evaporation System

Salts TPM 15 To TSDF, Dundigal (V),

Rangareddy District for land filling after stabilization. 6 ETP Sludge (Chemical

Sludge) TPM 8

7 Inorganic Salts from Process TPM 4 8 Used oil/Waste lubricating

oil TPM 1 To agencies authorized by

APPCB. 9 Spent Catalyst TPM 1 Shall be sent to manufacturers for

recovery. 10 Spent solvents KL/Month 250 Recovered within the premises

and reused into the process duly sending the residues to TSDF for incineration. 11 Mixed spent solvents KL/Month 100

12 Spent Acid TPM 3 Agencies authorized by APPCB. 13 Used lead acid batteries nos./year 30 Shall be returned to dealer on buy

back basis. 14 Detoxified Containers and

container liners of HW & hazardous chemicals

Shall be disposed after complete detoxification.

HDPE Drums no.s/Month 500 Plastic Bags Kg/Month 1000 Glass Bottles Kg/Month 500 Carboys no.s/Month 200


Page 12

Table A-9 Solid Waste Details – After Expansion (Tentative) S.No Name of the Hazardous

waste Units Quantity Disposal

1 Solvent Residue (Including SRS)

TPD 4.33 TSDF, Dundigal (V), Rangareddy District for Incineration / Authorized cement plants for co - processing. 2 Process Organic residue

3 Spent Carbon TPD 0.18 4 Spent Solvents & Spent

Mixed Solvents KLD 800 Recovered within the plant premises

/ Reused / Sold to Authorized third parties.

5 Inorganic residue TPD 0.29 TSDF, Dundigal (V), Rangareddy District for land filling. 6 Evaporation salts TPD 1.82

7 ETP Sludge TPD 1 8 Catalyst Kg/day 1 Sent to manufacturers for recovery. 9 Detoxified Containers and container liners of HW &

hazardous chemicals Shall be disposed after complete detoxification.

HDPE Drums no.s/Month 1500 Plastic Bags Kg/Month 2000 Glass Bottles Kg/Month 3000 Carboys no.s/Month 5000

10 Waste oil LPM 2000 Authorized Reprocessors / Recyclers.

11 Used batteries No.s/Year 30 Authorized Reprocessors / Recyclers.


Page 13

ANNEXURE – V: Stack Emissions Details

The sources of air pollution from the plant are from 3TPH existing Oil fired boiler, and DG

set of 1x 320 KVA, 1 x 250KVA. 1 x 500kVA existing and 1 x 1450kVA and 1 x 1010KVA

capacity.DG sets shall be provided with stack heights based on the CPCB formula for

effective stack height. The emission rates of SPM, SO2, NOx and SPM from each stack are


Table A-10 Stack Emission Details

S. No

Stack Connected to

Stack Ht (m)

Dia of stack at top(m)

Temp. of exhaust

gases (0C)

Exit Velocity (m/sec)

Pollutant Emission Rate

(g/sec) PM SO2 NOx

Permitted 1 3 TPH Oil Fired

Boiler 30.0 0.9 185 4.25 0.29 0.8 0.41

2* 320KVA DG Set 4.0 0.16 160 8.5 0.06 0.14 0.18 3* 250KVA DG Set 3.2 0.185 144 6 0.05 0.12 0.16 4* 500KVA DG Set 5.0 0.15 150 7.5 0.06 0.18 0.25

Proposed 1* 1450KVA

DG Sets 12 0.36 308 18 0.04 0.14 0.24

2* 1010KVA DG Sets 7.0 0.2 170 15.0 0.09 0.25 0.41

*DG sets will be removed


Page 14

Table A-11 Quantity of Process Emission Generated and Mode of Disposal – Proposed (Tentative)

Name of the Product Name of the Gas Quantity (Kg/Day) Mode of Treatment

Ramipril Hydrogen Chloride 28.47 To Scrubber Carbon Dioxide 15.54 Let into atmosphere Hydrogen 1.11 Let into atmosphere

Pantoprazole Sodium Oxygen 29.73 Let into atmosphere Ropinirole HCl Carbon Dioxide 0.33 Let into atmosphere

Hydrogen 1.28 Let into atmosphere Hydrogen Chloride 0.06 To Scrubber

Atomoxetine HCl Hydrogen Chloride 0.02 To Scrubber Tizanidine HCl Methyl Mercaptan 7.36 To Scrubber

Ammonia 2.60 To Scrubber Hydrogen Chloride 0.40 To Scrubber

Lacidipine Carbon Dioxide 0.87 Let into atmosphere Ammonia 0.33 To Scrubber

Aprepitant Chlorine 0.07 To Scrubber Hydrogen 0.02 Let into atmosphere

Voriconazole Butane 5.28 To Scrubber Hydrogen 0.71 Let into atmosphere Carbon Dioxide 0.58 Let into atmosphere




STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A-1, S.No. 150. (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B-115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad-500 038. Phone: 040-23748 555/616, Telefax: 040-23748666 Email: [email protected]

PLOT NO.116, 116B 126C, S.V. CO OP. IND. ESTATE...

Documents

Transcript of PLOT NO.116, 116B 126C, S.V. CO OP. IND. ESTATE...